Adipose TissueNCT00809029
The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Human Adipose Tissue: An In Vivo Study
A study testing GIP (glucose dependent insulinotropic peptide) infusion in people with Adipose Tissue, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Study part-1 GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones secreted by specialized cells of the gastrointestinal tract in response to ingestion of nutrients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Adipose Tissue
- What is being tested?
- GIP (glucose dependent insulinotropic peptide) infusion
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance
- Obese (BMI >30 kg/m2) subjects also with normal glucose tolerance.
- Obese with impaired glucose tolerance
- Obese with diet controlled diabetes mellitus
- Morbid obesity, type diabetes and post bariatric surgery (study part 2)
Who cannot join
- History of severe cardiac, hepatic or renal disease
- Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction)
- Current malignant disease
- Known alcohol misuse
- Major psychiatric disease (including current use of antidepressants)
- History of major eating disorder (anorexia or bulimia nervosa)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Aintree
Liverpool, L9 7AL
Christina Daousi, MD FRCP, +44 (0) 151 5295885, cdaousi@liverpool.ac.uk
Sravan K Thondam, MBBS MRCP, 44 (0) 151 5296464, s.thondam@liverpool.ac.uk
About this study
Official title: The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Hormone Sensitive Lipase, Lipoprotein Lipase And Adipokine Expression In Human Subcutaneous Adipose Tissue: An In Vivo Study
Study part-1
GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones secreted by specialized cells of the gastrointestinal tract in response to ingestion of nutrients. Data emerging from studies in animal models and cultured human fat cells support a physiological role for GIP in the adipose tissue metabolism which may contribute to the pathogenesis of obesity.
Read more
The proposed study will shed more light on the interactions between gut hormones and adipose tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from all subjects during both visits, once in the basal state (before the start of the peptide/placebo infusion) and then repeated at the end of the period of infusion.
Study part-2
Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from the physiological intestinal routes with subsequent profound modification of gut hormone secretion
We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal role in the improvement and/or restoration of diabetes, we propose to study patients (both sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will be compared to those of BMI matched control subjects with normal glucose tolerance
- Conditions
- Adipose Tissue
- Being tested
- GIP (glucose dependent insulinotropic peptide) infusion
- Keywords
- GIP, OBESITY, HSL, LPL, ADIPOCYTOKINES, BARIATRIC SURGERY
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP (glucose dependent insulinotropic peptide) infusionOther
Also called GIP (glucose dependent insulinotropic peptide)
an intravenous infusion of GIP (glucose dependent insulinotropic peptide)or placebo will be administered at a rate of 2 pmol/kg/min and maintained for 240 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure Lipoprotein lipase (LPL) and Hormone sensitive Lipase (HSL) activity in adipose tissue
Measured: Before and after 4 hours of infusion
Secondary outcomes (1)
To determine the role of GIP in adipocytokine gene expression and secretion from human subcutaneous adipose tissue
Measured: Baseline and after 4 hours of continuous infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startApr 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adipose TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DR CHRISTINA DAOUSI, Liverpool University Hospitals NHS Foundation Trust
- Investigators
- CHRISTINA DAOUSI, MD FRCP, Principal investigator, UNIVERSITY HOSPITAL AINTREE NHS TRUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809029
- Sponsor's protocol ID
- 08/H1001/20
- Other IDs
- 08DE001
- Status last verified
- Dec 2011
- First submitted
- 15 Dec 2008
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Hormone Sensitive Lipase, Lipoprotein Lipase And Adipokine Expression In Human Subcutaneous Adipose Tissue: An In Vivo Study
- ClinicalTrials.gov ID
- NCT00809029
- Acronym / sponsor ID
- 08/H1001/20
- Conditions
- Adipose Tissue
- Keywords
- GIP, OBESITY, HSL, LPL, ADIPOCYTOKINES, BARIATRIC SURGERY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study part-1
GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones secreted by specialized cells of the gastrointestinal tract in response to ingestion of nutrients. Data emerging from studies in animal models and cultured human fat cells support a physiological role for GIP in the adipose tissue metabolism which may contribute to the pathogenesis of obesity.
The proposed study will shed more light on the interactions between gut hormones and adipose tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from all subjects during both visits, once in the basal state (before the start of the peptide/placebo infusion) and then repeated at the end of the period of infusion.
Study part-2
Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from the physiological intestinal routes with subsequent profound modification of gut hormone secretion
We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal role in the improvement and/or restoration of diabetes, we propose to study patients (both sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will be compared to those of BMI matched control subjects with normal glucose tolerance
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance
- Obese (BMI >30 kg/m2) subjects also with normal glucose tolerance.
- Obese with impaired glucose tolerance
- Obese with diet controlled diabetes mellitus
- Morbid obesity, type diabetes and post bariatric surgery (study part 2)
Key exclusion criteria (6 listed)
- History of severe cardiac, hepatic or renal disease
- Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction)
- Current malignant disease
- Known alcohol misuse
- Major psychiatric disease (including current use of antidepressants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIP (glucose dependent insulinotropic peptide) infusionAlso: GIP (glucose dependent insulinotropic peptide)an intravenous infusion of GIP (glucose dependent insulinotropic peptide)or placebo will be administered at a rate of 2 pmol/kg/min and maintained for 240 minutes. | Other | – |
Primary outcome
To measure Lipoprotein lipase (LPL) and Hormone sensitive Lipase (HSL) activity in adipose tissue
Time frame: Before and after 4 hours of infusion
1 secondary outcome
To determine the role of GIP in adipocytokine gene expression and secretion from human subcutaneous adipose tissue
Time frame: Baseline and after 4 hours of continuous infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHRISTINA DAOUSI, MD FRCP principal investigator
UNIVERSITY HOSPITAL AINTREE NHS TRUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIP (glucose dependent insulinotropic peptide) infusion in people with Adipose Tissue, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHRISTINA DAOUSI, MD FRCP (+44 (0) 151 529 5920, cdaousi@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure Lipoprotein lipase (LPL) and Hormone sensitive Lipase (HSL) activity in adipose tissue (time frame: Before and after 4 hours of infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2011; AzTrials last refreshed its copy on 7 Nov 2026.